Journals of Gerontology: Medical Sciences

cite as: J Gerontol A Biol Sci Med Sci, 2018, Vol. 73, No. 8, 1053–1061
doi:10.1093/gerona/glx190
Advance Access publication 14 October 2017

Research Article

Strategies to Reduce Injuries and Develop Confidence in

Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of

Editor’s choice
a Multifactorial Fall Injury Prevention Strategy: Design
and Methods
Shalender  Bhasin, MB, BS,1,* Thomas M.  Gill, MD,2,* David B.  Reuben, MD,3,*
Nancy K.  Latham, PhD, PT,1,* Jerry H.  Gurwitz, MD,4
Patricia  Dykes, RN, PhD, MA,5 Siobhan  McMahon, PhD, MPH, GNP-BC,6
Thomas W.  Storer, PhD,1 Pamela W.  Duncan, PhD, PT,7
David A.  Ganz, MD, PhD,3 Shehzad  Basaria, MD,1 Michael E.  Miller, PhD,7
Thomas G.  Travison, PhD,8 Erich J.  Greene, PhD,9 James  Dziura, PhD,9
Denise  Esserman, PhD,9 Heather  Allore, PhD,9 Martha B.  Carnie, AS,5
Maureen  Fagan, DNP, MHA,FNP-BC,5 Catherine  Hanson, BA,10
Dorothy  Baker, PhD,2 Susan L.  Greenspan, MD,11 Neil  Alexander, MD,10
Fred  Ko, MD, MS,12 Albert L.  Siu, MD, MPH,12 Elena  Volpi, MD, PhD,13
Albert W.  Wu, MD, MPH,14 Jeremy  Rich, DPM,15
Stephen C.  Waring, DVM, PhD, 16
Robert  Wallace, MD, MSc,17
Carri  Casteel, PhD,17 Jay  Magaziner, MSHyg, PhD,18 Peter  Charpentier, MPH,9
Charles  Lu, PhD,9 Katy  Araujo, MPH,9 Haseena  Rajeevan, PhD,9
Scott  Margolis, MBA,1 Richard  Eder, BA,1
Joanne M.  McGloin, MDiv, MS, MBA,2
Eleni  Skokos, BS, MS,2
Jocelyn  Wiggins, BM, BCH,10 Lawrence  Garber, MD,4 Steven B.  Clauser, PhD, MPA,19
Rosaly Correa-De-Araujo, MD, MS, PhD,20 and Peter Peduzzi, PhD9,*
1
Pepper Older Americans Independence Center, Research Program in Men’s Health: Aging and Metabolism, Brigham and Women’s
Hospital, Boston, Massachusetts. 2Pepper Older Americans Independence Center, Yale University, New Haven, Connecticut. 3Multicampus
Program in Geriatrics Medicine and Gerontology, David Geffen School of Medicine at UCLA, Los Angeles, California. 4Meyers Primary
Care Institute, Reliant Medical Group, Worcester, Massachusetts. 5Brigham and Women’s Hospital, Boston, Massachusetts. 6School of
Nursing, University of Minnesota, Minneapolis. 7Wake Forest University, Winston-Salem, North Carolina. 8Hebrew SeniorLife, Harvard
Medical School, Boston, Massachusetts. 9Yale Center for Analytical Sciences, Yale University, New Haven, Connecticut. 10University of
Michigan, Ann Arbor. 11Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh,
Pennsylvania. 12Mount Sinai School of Medicine, New York, New York. 13University of Texas Medical Branch, Galveston. 14Johns Hopkins
University, Baltimore, Maryland. 15HealthCare Partners, El Segundo, California. 16Essentia Health, Duluth, Minnesota. 17University of
Iowa, Iowa City. 18University of Maryland, Baltimore. 19Patient Centered Outcomes Research Institute, Washington, District of Columbia.
20
National Institute on Aging, Bethesda, Maryland.

*The authors indicates that these authors contributed equally.

Address correspondence to: Shalender Bhasin, MB, BS, Professor of Medicine, Harvard Medical School, Director, Research Program in Men’s
Health: Aging and Metabolism, Brigham and Women’s Hospital, 221 Longwood Avenue, Boston, MA 02115. E-mail: sbhasin@bwh.harvard.edu

© The Author(s) 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved.
1053
For permissions, please e-mail: journals.permissions@oup.com.
1054 Journals of Gerontology: MEDICAL SCIENCES, 2018, Vol. 73, No. 8

Received: June 25, 2017; Editorial Decision Date: September 21, 2017

Decision Editor: Anne Newman, MD, MPH

Abstract
Background:  Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to
compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care.
Methods:  Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group,
superiority, pragmatic trial being conducted at 86 primary care practices in 10 health care systems across United States. The 86 practices were
randomized to intervention or control group using covariate-based constrained randomization, stratified by health care system. Participants
are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a comanagement model in which a
nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up
evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based
information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (nonvertebral
fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-
being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to
provide 90% power to detect 20% reduction in primary outcome rate relative to control.
Results:  Trial enrolled 5,451 subjects in 20 months. Intervention and follow-up are ongoing.
Conclusions:  The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older
adults.

Keywords: Fall prevention, Clinical effectiveness, Patient and stakeholders in fall injury prevention research, Nurse falls care managers.

Falls are the leading cause of fatal and nonfatal injuries among older (DSMB), established by the NIA, meets every 6 months to oversee
adults, accounting for an estimated 424,000 deaths annually world- the trial’s progress and safety.
wide. Approximately one in three older Americans falls each year,
and 20%–30% of those who fall suffer moderate to severe injuries Pilot Phase
(1–3). In 2010, 2.3 million nonfatal fall injuries were treated in emer- During the pilot phase in Year 1, we established organizational
gency departments and more than 662,000 of these patients were structure and trial infrastructure, drafted the trial protocol and the
hospitalized (4). Among those who fall but do not sustain an injury, Manual of Procedures, and undertook training of investigators,
many develop fear of falling and limit their activities (5). Therefore, study staff, and FCMs. We pilot tested the screening and recruitment
strategies to prevent fall injuries are a major public health concern in procedures to determine feasibility and yields of different recruit-
the United States and worldwide. ment strategies.
There is abundant evidence that many falls in the elderly are Pilot testing was completed at one practice at each of the 10 trial
preventable (6–8). Unfortunately, fewer than half of those who fall sites. A  total of 164 participants were identified using 5 screening
discuss fall prevention with a health care provider (9), and only a questions to assess high risk for serious fall injuries; 82% of partici-
third of elderly patients are screened for fall risk. Thus, the quality of pants were identified on the basis of three core screening questions
care for those at risk for falling has not improved in the past decade from an Assessing Care of Vulnerable Elders (ACOVE) study (11):
(10) and there is an unmet need for prevention strategies that are “Have you fallen 2 or more times in the past year?”, “Have you
cost-effective and easily deployed at the site of clinical care. fallen and hurt yourself in the past year?”, and “Are you afraid that
Recognizing that fall injuries are a major public health problem, you might fall because of balance or walking problems?” Two add-
the Patient Centered Outcomes Research Institute (PCORI) and the itional questions, “Do you have difficulty maintaining your balance
National Institute on Aging (NIA) awarded a 5-year cooperative when bathing, dressing or getting in and out of chair?” and “Do you
agreement to conduct a pragmatic trial to determine the effectiveness usually use a cane, walker or other device when walking inside or
of a patient-centered intervention that combines elements of practice outside your home?” were pilot tested but offered little additional
redesign and an evidence-based, multifactorial, individually-tailored information beyond that provided by the 3 core questions, and were
intervention implemented by nurse Falls Care Managers (FCM) in subsequently omitted from the screening questionnaire. During the
primary care settings. We describe here the overall design of this pilot phase, local and central screening were evaluated and based on
pragmatic trial. feasibility, yields and costs, central screening was chosen as the pri-
mary strategy for the trial.
The FCMs, recruited by each trial site, completed a
Methods custom-designed 24-module training program. During the pilot
The trial is a pragmatic, multisite cluster-randomized, parallel group, phase, the FCMs, assisted by local patients and stakeholders, iden-
superiority trial among noninstitutionalized older persons. The pri- tified services and care providers within the health care system and
mary outcome of the trial is serious fall injuries. in the community. The study team created structured notes for clin-
The Brigham and Women’s Hospital established a special ical assessment, materials that could be given to patients to enable
Institutional Review Board (IRB), with a designated chair, that them to access these health care services, and referral notes that
serves as the central IRB (cIRB) and approved the STRIDE protocol could be sent to these services. The intervention was pilot tested
and amendments. A 9-member Data and Safety Monitoring Board at each trial site.
Journals of Gerontology: MEDICAL SCIENCES, 2018, Vol. 73, No. 8 1055

Design of Main Trial reported an average of 2.1 chronic conditions; the most common
STRIDE is a cluster-randomized, pragmatic clinical trial set in pri- chronic conditions were hypertension (65%), cancer (26%), arth-
mary care practices, with practices stratified by health care system ritis (21%), and diabetes (20%). Thirty-nine percent had a fall with
and patients nested within practices. The unit of randomization is injury during the past year and 35% had two or more falls during
the practice. This avoids the potential for contamination of controls, the past year.
allows staff to be trained efficiently, and improves the feasibility
of applying the intervention practice-wide. The trial’s duration is Screening and Recruitment
40 months, including 20 months of recruitment and a minimum of Based on the results of the pilot phase, our primary recruitment
20-months of follow-up. The primary outcome is time to first serious strategy was centralized screening through the Yale Recruitment
fall injury assessed at the patient level. and Assessment Center (RAC) at 9 of the 10 trial sites. The clinic
sites provided the RAC with the names and addresses of age-eligible
Trial Sites patients in each practice. These patients were sent a letter addressed
The trial is being conducted at 86 primary care practices in 10 health from their primary care providers asking them to complete the
care systems across the United States: Essentia Health; HealthCare falls screening questionnaire, which included the three questions in
Partners; Johns Hopkins Medicine; Mercy Health; Michigan Table 1, and mail it back to the RAC. Additional mailings were sent
Medicine, Mount Sinai Health; Partners Healthcare; Reliant Medical to non-responders to improve response rates.
Group; University of Pittsburgh Healthcare; and University of Texas A clinic screening strategy was used at the Reliant Medical
Medical Branch Galveston. These health care systems reflect the ra- Group in which practice staff screened all age-eligible patients dur-
cial and ethnic diversity of the U.S.  population, and include rural, ing primary care visits as a part of standard vital signs.
urban, and suburban sites, and diverse reimbursement plans.
Recruitment
Selection of Practices All patients who screened positive were mailed a recruitment packet
A Practice Selection Committee evaluated 116 primary care prac- which included an invitation letter from the patient’s practice and a
tices and selected 86 practices to be randomized using pre-specified study information sheet. The invitation letter indicated that the sub-
eligibility criteria, including practice size, the ability to implement ject could opt out from being contacted about the study by returning
the intervention, and availability of electronic medical record (EMR) a self-addressed postcard within 2 weeks.
data. Eligible practices were required to have access to one or more All screen-positive patients who did not opt out were called by
community-based exercise programs aimed at preventing falls a RAC staff member masked to treatment allocation. During this
within reasonable proximity. The geographic proximity of practices telephone interview, the interviewer confirmed the absence of any
was also considered to mitigate the potential for contamination of exclusion criteria; administered the Callahan screener; reviewed
intervention and to minimize FCM’s travel. Practices that were pri- study’s purpose; and answered any questions. After obtaining verbal
marily geriatric medicine clinics were excluded. Practices that shared consent, baseline data, including demographics, chronic conditions,
physicians were excluded to avoid contamination bias that could re- falls history, self-rated health, and height and weight, were collected.
sult if these practices were randomized to different treatment groups. Written consent was not obtained. Information about secondary
outcomes also was collected among a random subset of 714 partici-
pants (see sample size estimates).
Cluster Randomization
Eighty-six eligible practices were randomized to either the inter-
vention or the control group using covariate-based, stratified, con- Intervention
strained randomization (12,13) to balance practice characteristics The intervention, described in detail in another manuscript (15), is an
within and across the 10 health care systems. The randomization individually tailored set of recommendations/interventions (16,17)
was stratified by health care system and the balancing covariates based on multifactorial risk assessment that utilizes a primary care
were practice size, urbanicity (urban vs rural), and race/ethnicity comanagement model implemented by a nurse FCM (Table 2). The
(whether the practice was predominantly White or non-White). maximum duration of intervention is 40  months and minimum
Randomization was completed prior to participant enrollment. 20 months, for an average intervention duration of 30 months. The
Only the biostatisticians participated in randomization and practice
names were masked.
Table 1.  Inclusion and Exclusion Criteria
Participants Inclusion Criteria
After 9 months of recruitment, the initial age limit of 75 was low- i. The patient is at least 70 years of age.
ered to 70 to increase the recruitment pool. Patients were eligible ii. The patient must answer “yes” to one or more of the following
if they were identified as being at increased risk of fall injuries by questions:
answering yes to one or more of the three fall-related questions, and A Have you fallen and hurt yourself in the past year?
if they were able to provide telephone consent or proxy consent with B Have you fallen two or more times in the past year?
patient assent (Table  1). To enhance generalizability, the exclusion C Are you afraid that you might fall because of balance or walking
problems?
criteria were kept to a minimum. Patients found to have significant
Exclusion Criteria
cognitive impairment, defined as four or more errors on the 6-item
i. The patient is enrolled in hospice.
Callahan screener (14), were required to have a proxy/caregiver will- ii. The patient resides in a nursing home.
ing to provide consent and assist the participant in the study. The patient is not capable of providing informed consent (or
The mean age of the enrolled participants was 80 years; 62% were assent), and a proxy is not available.
women, 13% were African American or Hispanic. The participants iv. The patient does not speak English or Spanish
1056 Journals of Gerontology: MEDICAL SCIENCES, 2018, Vol. 73, No. 8

Table 2.  Key Elements of the Intervention Table 3.  Fall Risk Factors and Triggers for Intervention

1. Risk assessment by a FCM using standardized history-gathering and Risk Factor Triggers
physical examination documented in a structured visit note.
2. Use of evidence-based algorithms to identify recommended Strength, balance, gait All patients
treatments that are discussed with participants impairment.
3. Explanation of identified risks to the patient (and caregiver, when Medications FRIDs or symptoms identified from
appropriate) and suggested interventions, using motivational Previsit Questionnaire
interviewing to elicit patient preferences and readiness to participate Vitamin D deficiency All patients not currently taking Vitamin
in treatments D
4. Cocreation, with FCMs and patients (and caregivers, as appropriate), Home safety Risk factors identified by the FCM
of an individualized Falls Care Plan that is presented to the patient’s on home safety checklist filled by all
PCP for modification and approval, to include: patients prior to initial visit
a. Fall risk reduction interventions that the FCM can directly Orthostatic hypotension Orthostatic hypotension identified
implement; during initial visit
b. Recommendations that the PCP can implement (eg, medication Visual impairment Patients who have not been seen by eye
changes); doctor in past year, or Patients who have
5. Referrals to health providers or community-based organizations for vision risk factors (macular degeneration,
more detailed assessment or implementation of specific components glaucoma, diabetic eye disease, near or
identified in the Risk Assessment. far vision loss) even if they have seen an
6. Ongoing monitoring of response to treatment as indicated in the eye doctor within the past year.
Care Plan and reassessment of risk factors at scheduled intervals by Foot problems or unsafe All patients depending upon assessment
the FCM with revision of the Care Plan as needed. footwear findings
Osteoporosis All patients
Note: FCM = Falls Care Managers; PCP = Primary care provider.
Note: FCM = Falls Care Managers; FRID = Fall Risk Increasing Drugs.

FCMs are registered nurses, who completed a 24-module fall preven-

Adherence to the intervention is measured by the percentage of
tion and management program custom-developed by the STRIDE
persons randomized to the intervention arm who receive an initial
team, along with individualized training in the management of
evaluation for risk factors, the percentage of risk factors assessed for
patients at risk for falls. A FCM Nursing Director provided ongoing
each participant, and the percentage of identified positive risk fac-
support and supervision through scheduled weekly conference calls
tors for which an action is taken according to the clinical protocols.
and annual in-person training sessions.
The FCM assesses each participant for 7 modifiable falls risk fac-
tors (17) (Table 3), explains the identified risks to the patient (and Control intervention
caregiver, as appropriate), and suggests interventions, based on the The participants in the control practices receive enhanced usual
person’s risk factors and STRIDE algorithms for each risk factor. The care. These participants receive a falls informational booklet, enti-
FCM uses motivational interviewing to elicit patient preferences and tled “Stay Independent”, which is part of the STEADI toolkit, and
readiness to participate in treatments. The FCM creates an individu- they are encouraged to discuss fall prevention with their PCP at their
alized Falls Care Plan and presents it to patient’s primary care pro- next clinic visit. Their physicians receive the results of the screening
vider (PCP) for approval. This individualized Falls Care Plan includes questions and are referred to a training webinar about fall preven-
fall risk reduction interventions that the FCM can independently im- tion adapted from the STEADI toolkit (16).
plement, recommendations that the PCP can implement (eg, medica-
tion changes), and referrals to health providers or community-based Outcomes
organizations for implementation of specific components identified The primary outcome is time to first serious fall-related injury,
in the Risk Assessment. During regularly scheduled follow-up visits defined as falls leading to medical attention, including nonverte-
or phone calls, the FCM evaluates patients’ progress in Falls Care bral fractures, joint dislocation, head injury, lacerations, and other
Plan implementation and response to intervention; reassesses risk major sequelae (eg, rhabdomyolysis, internal injuries, hypothermia)
factors; and revises the Falls Care Plan as needed. After the initial (Table  4). In a supportive analysis, all serious fall injuries will be
evaluation by the FCM, follow-up visits take place at least once an- evaluated.
nually. Additional phone calls take place at least once during the first Secondary outcomes include all fall injuries and all falls, defined
year and every 6 months in subsequent years. as an unexpected event in which the participant comes to rest on
The principal components of the intervention—the FCM, sys- the ground, floor, or lower level (18). We collect data on falls, ser-
tematic assessment of risk factors, patient engagement, the linkage ious fall injuries, and other fall injuries every 4  months in all par-
with health care providers, and referrals to community-based pro- ticipants (Table 5) using a structured telephone interview, conducted
grams—are consistent across practices. However, some variation by masked interviewers, which also asks about hospital admissions,
in the implementation of the intervention at the trial sites was ne- emergency department (ED) visits, and other health care utilization.
cessary, depending upon local resources, availability of community- To facilitate recall, participants are provided a monthly fall calendar
based programs, or other site-specific factors. to record their falls and injuries. The ascertainment of these out-
Structured notes from the initial and follow-up visits and clin- comes is conducted by the RAC.
ical documents (eg, previsit questionnaire, home safety checklist) are Secondary well-being outcomes include concern about falling,
entered into an electronic health record and into a specially designed anxiety and depressive symptoms, and physical function and dis-
FCM software application. The falls events are managed by the pri- ability. Concern about falling is ascertained using the Fall Efficacy
mary practice and FCM according to standards of care. Scale (FES) (19); physical function and disability using the computer
Journals of Gerontology: MEDICAL SCIENCES, 2018, Vol. 73, No. 8 1057

Table 4.  Primary and Secondary Outcomes of the STRIDE Study

Outcome level Outcome Measure Ascertainment

Primary Serious fall injuries defined as falls leading to medical attention, including Every 4-month interviews aided by monthly fall
nonvertebral fractures, joint dislocation, head injury, lacerations, and other calendars; encounter and claims data; electronic
major sequelae (eg, rhabdomyolysis, internal injuries, hypothermia) medical records
Secondary Fall-Related Every 4-month interviews aided by monthly fall
calendars; encounter and claims data
  All fall injuries
  All falls*
Wellbeing measures Measured at baseline, 12 and 24 months
  Concern for falling Fall efficacy scale
  Depressive symptoms PROMIS scales for depressive symptoms and
anxiety
 Anxiety CAT version of Late Life Function and Disability
Instrument
  Physical function and disability
Tertiary Hospitalizations Every 4-month interviews; encounter and claims
data; electronic medical records if needed
Nursing home admissions

Note: *A fall was defined as an unexpected event in which the participant comes to rest on the ground, floor, or lower level. A modified caregiver FES was used
in patients who had a caregiver. CAT = Computer Adaptive Testing; FES = Fall Efficacy Scale; PROMIS = Patient-Reported Outcomes Measurement Information
System.

Table 5. The Trial’s Schedule of Events

Activity/Assessment Screen Baseline 4 mo 8 mo 12 mo 16 mo 20 mo 24 mo 28 mo 32 mo 36 mo 40 mo

Screen
Screen for high fall risk X
Telephone interview X
Consent/Assent X
Demographic characteristics X
Cognitive screen X
Chronic conditions X
Fall history X
Self-rated health, height/weight X
Physical function and disabilitya X X X
Concern about fallinga X X X
Anxiety/depressive symptomsa X X X X
Phone interviews for fall X X X X X X X X X X
ascertainmenta
Falls, fall injuries, serious fall X X X X X X X X X X
injuries
Health care utilization X X X X X X X X X X

Note: After the initial visit with the FCM, follow-up visits take place at least once annually. Additional FCM phone calls take place at least once during the
first year and every 6 months in subsequent years. The exact timing of the FCM visits and telephone calls depends on the patient and FCM availability and other
factors. FCM = Falls Care Managers.
a
Among a random subset of 714 participants.

adaptive technology version of Late Life Function and Disability physicians from the central STRIDE team, will be involved in adju-
Index (20,21); and anxiety and depressive symptoms using the dication of the primary outcome. An injury will be deemed to meet
PROMIS scales (22). Wellbeing outcomes are being collected in a the definition of the primary outcome if the injury is related to a fall,
13% subsample at 12 and 24 months. the injury leads to use of health care services, and the injury falls into
a predefined list of types (nonvertebral fractures, joint dislocation,
Fall Injury Adjudication head injury, lacerations, or “other major sequelae”).
The primary outcome—serious fall injuries—will be adjudicated Two site-based adjudicators will be responsible for initial adju-
by an Adjudication Committee using three sources of informa- dication of each case. The central STRIDE team of two adjudica-
tion: 4-monthly RAC interviews, informed by monthly fall calen- tors will review a stratified random sample of 5% of all cases to
dars; encounter data from the clinical trial sites or claims data from assure consistency in adjudication. If the two site-based adjudica-
Center for Medicare Services (CMS); and specific information tors do not agree, a third adjudicator may be enlisted to break
from the EMR. One physician from each of the ten sites, plus two the tie.
1058 Journals of Gerontology: MEDICAL SCIENCES, 2018, Vol. 73, No. 8

Statistical Design DSMB also has approved a revision to the plan specifying that a
STRIDE was designed as a pragmatic trial with the following adap- formal interim analysis for efficacy or futility with the potential for
tive features: (i) modifying the eligibility criteria if enrollment is early termination may not be necessary, and that a final decision
lower than expected (eg, by lowering the eligibility age); (ii) modi- about a formal interim analysis can be made sometime in 2018.
fication of primary outcome definition if there is evidence of as-
certainment bias because of interactions between the FCMs and Sample Size
participants; (iii) changing the primary outcome from first serious Sample size was first determined for an unclustered design with
fall injury to all serious fall injuries if the former rate is too low, a time-to-first event outcome in the presence of a competing risk
affecting statistical power; (iv) interim monitoring for efficacy or fu- due to death using PASS software, and then inflated for clustering
tility, if necessary and (v) refining the analytic methods based on the and interim monitoring. A  target sample size of 6000 participants
validity of assumptions. All adaptations, except for interim look, will was selected based on the following assumptions: (i) 18-month re-
be done masked to treatment. cruitment period and a trial duration of 36 months with minimum
follow-up of 18 months; (ii) type I error = 5% (two-sided) and 90%
Analytic approach power; (iii) uniform accrual; (iv) equal allocation to intervention and
All analyses will consider practices according to their randomized control groups; (v) no adjustment for nonadherence to intervention
assignment regardless of adherence to protocol, and will account for (accounted for with conservative treatment effect); (vi) all patients
cluster design with the participant as the unit of analysis. The analysis followed to trial’s end; (vii) 7% annual death rate without experienc-
of the primary outcome, time to first serious fall injury, will use a sur- ing a serious fall injury (ie, competing risk); (viii) 3% annual loss-to-
vival model that incorporates clustering and competing risk of death follow-up in the absence of serious fall injury or death (expected to
(23–25). The model will be adjusted for stratified randomization of be low due to the use of multiple sources, including claims data); (ix)
practices by health care system and include the balancing covariates 3% inflation for the proposed interim monitoring for efficacy and
used in assignment of practices (practice size, location, and ethnicity). futility; and (x) 53% inflation for the design effect (DE) of cluster-
Participants without a serious fall injury will be censored either at the ing, based on 86 practices each enrolling 70 participants and an ICC
date of their withdrawal or at the end of follow-up. In a secondary of 0.0076 estimated from an analysis of serious fall injuries in the
analysis, we will adjust for a prespecified set of baseline covariates to LIFE Study (27). The target effective number of serious fall injuries
examine their influence on treatment effect: age, race/ethnicity, edu- to detect a 20% reduction for intervention relative to control at 90%
cation, number of chronic conditions, and number of positive screen- power is 844.
ing items. Model fit will be assessed using standard approaches (eg, Because of slower than expected enrollment in the initial
examination of Martingale residuals and the proportional hazards 6 months of the trial, the DSMB approved the extension of recruit-
assumption). The effect of intervention relative to control will be ment period to 20  months and the minimum follow-up period to
estimated as a subdistribution hazard ratio with corresponding 95% 20  months for a total 40-month trial duration. These extensions
confidence intervals. Also, we will obtain an estimate of the inter- reduced sample size requirements to 5,322 participants given the
vention effect at the practice level. If the intervention is effective in above assumptions.
reducing the risk of serious fall injuries, its effect will be evaluated At the completion of the 20-month recruitment period, the trial
in subgroups of participants using appropriate tests of homogeneity had accrued 5,451 subjects, and the enrollment was stopped, as
(eg, interaction) defined by prespecified covariates. The cumulative planned; 714 were enrolled in the subsample.
incidence of serious fall injuries will be estimated using nonparamet-
ric maximum likelihood methods (24) and used to estimate freedom Safety Monitoring
from falling over the entire follow-up period. In a supportive analysis, Because the intervention was considered standard of care and not
we will evaluate serious fall injuries as a recurrent event using a joint research, the consent form did not include language for consent to an
frailty model that accounts for clustering, censoring and competing intervention, only for collecting data. However, the study is monitor-
risk (26). An overall type I error rate of 0.05 (two-sided) will be used ing for two serious adverse events, hospitalizations and death using
as the level of significance for primary endpoint. the RAC interviews conducted every 4  months, EMR review, and
encounter data from the trial sites or CMS claims data.
Analysis of the secondary outcomes
The time-to-event analysis of the secondary outcomes—all fall inju- Integration of Patient and Stakeholders in Trial’s
ries and all falls (regardless of injury)—will be performed similar to Planning and Implementation
the primary outcome. Indicators of well-being (fall efficacy, physical
A unique aspect of the STRIDE study is the inclusion of input from
function, anxiety and depressive symptoms) measured in the 13%
a patient and stakeholder group to facilitate the bidirectional pro-
subsample will be analyzed using generalized linear mixed models
cess of engaging patients and other stakeholders both locally at the
assuming missing at random (MAR) with adjustment for factors
10 trial sites, and centrally at the central project management level.
that are found to be predictive of missingness. Sensitivity analyses
This engagement started during the planning of the project and has
will be conducted to investigate the MAR assumption, such as meth-
continued throughout the trial’s implementation. A National Patient
ods that model jointly the missingness and outcome distributions.
and Stakeholder Council (NPSC) which includes patients, caregivers,
Adjustments for multiplicity will be used to control type I error for
representatives from patient and family-centered care programs, rep-
the secondary endpoints (eg, Hochberg procedure).
resentatives of local or national government agencies on aging, and
from the NIA and PCORI, is led by two cochairs, one of whom is a
Interim monitoring patient. The NPSC then worked with the leadership of the trial sites
An interim monitoring plan, which encompasses the adaptive de- to establish 10 Local Patient and Stakeholder Councils (LPSCs), one
sign features described earlier, has been approved by the DSMB. The at each trial site. The membership of NPSC and LPSCs is diverse in
Journals of Gerontology: MEDICAL SCIENCES, 2018, Vol. 73, No. 8 1059

terms of the type of stakeholder, sex, race, ethnicity, and geographic The project has drawn upon a diverse set of patients, caregivers and
region. The LPSCs includes patients, caregivers, representatives other stakeholders, who have participated in all the committees and
from the local community; health care professionals, advocates for in-person focus groups to craft the recruitment strategy, intervention,
consumer groups, and local area Agencies on Aging. Each LPSC is and outcomes. The STRIDE study’s successful experience in integrating
cochaired by a facilitator and a patient stakeholder. patients and stakeholders into the study team can inform the design
The NPSC serves in a consultative capacity to study lead- and implementation of other patient-centered outcomes research.
ership, local councils and site PIs, and provides input from the The 10 trial sites reflect the diversity of the U.S.  health care
10 local councils to the trial’s PIs and committees. All STRIDE system with respect to models of care and payment, geography, and
committees have at least one NPSC member. The NPSC and the race/ethnicity. The successful implementation of the intervention in
LPSCs have provided important input into screening, recruitment, such diverse healthcare systems would provide strong evidence of
intervention, and retention strategies; crafting recruitment pack- its scalability. Although small group practices were not included, the
ages; reviewing patient-facing materials; and in selecting study lessons learned here may inform smaller practices. The intervention
outcomes. The LPSCs have also supported FCM(s) by facilitating has been designed to be replicable within other health systems (eg,
connections with community resources needed for intervention the Department of Veterans Affairs) and in small practices that par-
implementation. ticipate in independent practice associations or Accountable Care
Organizations.
The trial enlisted the expertise of scientists, patients, and stake-
Discussion holders from across the country, including many NIA-funded
As one of the largest trials of fall injury prevention, the STRIDE Claude D.  Pepper Older Americans Independence Centers. Thus,
Study has important clinical and public health implications. The trial the STRIDE study represents an important national effort, whose
addresses barriers to quality falls care by identifying the best avail- results will greatly impact clinical practice as it relates to fall injury
able evidence, redesigning practice to ensure that evidence-based prevention.
care is provided, and involving researchers, clinicians, patients,
and other key stakeholders in the implementation of the study. The
resulting approach to preventing fall injuries follows three principles Funding
that should ensure its success and dissemination; it is (i) evidence- The STRIDE study was funded primarily by the Patient Centered Outcomes
based, (ii) patient-centered, and (iii) scalable. Research Institute (PCORI), with additional support from the National
The trial tests strategies with proven efficacy on falls quality Institute on Aging (NIA) at NIH. Funding is provided and the award man-
aged through a cooperative agreement (5U01AG048270) between the NIA
of care and outcomes into one cohesive intervention that can be
and the Brigham and Women’s Hospital. The project is part of the Partnership
adopted by many health systems. These strategies include multifac-
for Fall Injuries Prevention between the NIA and PCORI. Additional support
torial, individually-tailored, evidence-base interventions) (6,7,11)
was provided by the Boston Claude D. Pepper Older Americans Independence
selected by activated, engaged patients. The design of the study Center at Brigham and Women’s Hospital (P30-AG013679); Harvard Catalyst
incorporates strategies to overcome challenges in implementation | The Harvard Clinical and Translational Science Center (National Center for
of a pragmatic trial conducted in large and diverse health systems. Research Resources and the National Center for Advancing Translational
Thus, the core pillars of the intervention are implemented faithfully Sciences, National Institutes of Health Award UL1 TR001102) and financial
across trial sites but the sites are afforded some latitude in varying contributions from Harvard University and its affiliated academic healthcare
the implementation of specific components based on local practices centers; the Claude D. Pepper Older Americans Independence Centers at Yale
and resources. Cluster randomization with practice serving as the University (P30AG021342) and by the NIH/National Center for Advancing
Translational Sciences Clinical and Translational Science Awards program
unit of randomization avoids the potential for contamination of
at Yale University (UL1TR000142). T.M.G.  is the recipient of an Academic
controls, allows staff to be trained efficiently, and improves the feasi-
Leadership Award (K07AG043587) from the National Institute on Aging.
bility of applying the intervention practice-wide.
Recognizing that no single method for fall injury ascertainment
is perfect, the trial combines three strategies—every 4-month phone Acknowledgments
interviews aided by fall calendars, CMS claims and health system
The STRIDE Study Team
encounter data, and electronic medical records—to adjudicate ser-
Joint Principal Investigators:
ious fall injury. Shalender Bhasin, MB, BS, Communicating PI and Chair of the Steering and
The STRIDE trial was designed with a keen focus on the scal- Publications Committees, and Central Project Management (Brigham and
ability of its intervention strategies to other health care systems and Women’s Hospital, Harvard Medical School, Boston, MA)
populations. The trial has been integrated into 86 primary care prac- Thomas M. Gill, MD, PI and Chair of Protocol and Recruitment Committees
tices of 10 diverse “real world” health care systems. The processes (Yale School of Medicine, New Haven, CT)
for practice redesign, patient co-management, and intervention for David B. Reuben, MD, PI and Chair of Intervention Committee (David Geffen
each risk factor have been successfully woven into the practices and School of Medicine at UCLA, Los Angeles, CA)
School of Nursing, University of Minnesota
their EMRs. Each practice has developed the needed collaborations
Siobhan McMahon, PhD, MPH GNP-BC (Nursing Director)
with community resources. The STRIDE team has developed tools
Central Project Management, Brigham and Women’s Hospital, Boston, MA:
that can be used by other health care systems and clinicians; exam-
Shalender Bhasin (PI), Nancy K. Latham, PhD PT (Study Director), Shehzad
ples of such tools include manuals and videos for training of FCMs, Basaria, MD (Chief Medical Safety Officer), Richard Eder, BA (cIRB Liaison),
rehabilitation therapists, and providers; algorithms for identifying Amy Larson, MHA (Administrative Director), Lori Goehring, BA (Study
persons at risk of falls and for prevention of fall injuries at a systems Manager), Molly Lukas, BS, Scott Margolis MBA, Thomas W.  Storer, PhD,
level; and information technology platforms that facilitate interven- Priscilla Gazarian, PhD, RN, Maureen Fagan, DNP, MHA, FNP-BC, Martha
tion’s integration with EMR. B. Carnie, AS
1060 Journals of Gerontology: MEDICAL SCIENCES, 2018, Vol. 73, No. 8

Data Coordinating Center, Yale University, New Haven, CT: Screening; Recruitment and Retention: Joanne M.  McGloin, M Div, MS,
Peter Peduzzi (Director), PhD, James Dziura, PhD, Denise Esserman, PhD, MBA and Thomas M. Gill, MD
Erich J.  Greene, PhD, Geraldine Hawthorne-Jones, Heather Allore, PhD, Data Management and IT: Peter Charpentier, MPH
Margaret Doyle, Brian Funaro, Nancy Lorenze DNSc, Bridget Mignosa, Intervention: David B. Reuben, MD
Michael E. Miller, PhD (Wake Forest), Thomas G. Travison, PhD (Harvard), Safety: Shehzad Basaria, MD
Peter Charpentier, MPH (Chair of Data Management Committee), Katy Falls Care Managers: Siobhan McMahon, PhD, RN (University of Minnesota);
Araujo, MPH National Patient and Stakeholder: Maureen Fagan, DNP, MHA, FNP-BC
Yale School of Medicine, New Haven, CT: (Chair), Martha B. Carnie, AS (Co-Chair), Catherine Hanson, BA
Geriatric Medicine: Physical Components: Pamela W. Duncan, PhD, PT (Wake Forest University)
Dorothy Baker, PhD and Thomas W. Storer, PhD
Recruitment and Assessment Center: FCM Training: Chad Boult, MD, MPH, MBA (Johns Hopkins) and Priscilla
Joanne M. McGloin, MDiv, MS, MBA, Charles Lu, PhD, Haseena Rajeevan, Gazarian, PhD, RN
PhD, Liliya Katsovich, MA, MBA, CCRP, Rixin Wang, PhD, Amy Shelton, Ancillary Studies: James Goodwin, MD (UTMB) and Todd Manini, PhD
MPH, Eleni Skokos, BS, MS, Sui Tang, BS, Mara Abella, Carol Gordon, (University of Florida) Publications: Shalender Bhasin, MB, BS and Peter
Teresita Pennestri, Luann Bianco, Rina Castro, Sabina Rubeck, Kenneth Peduzzi, PhD
Rando, Barbara Foster, Karen Wu, David Nock, Crysta Collins, Eloisa Wake Forest University, Winston-Salem NC
Martinez (UTMB), Leo Sherman (Mt. Sinai) Kevin P. High, MD, MS, Lea Harvin, Cindy Stowe
Clinical Trial Sites National Institute on Aging, Bethesda, Maryland:
Essentia Health, Duluth, MN Program Officer: Sergei Romashkan, MD, Scientific Officer: Rosaly Correa-
Site Principal Investigator: Stephen C. Waring, DVM, PhD, Fall Care Manager: De-Araujo, MD, MS, PhD, Lyndon Joseph, PhD, Marcel Salive, MD, MPH,
Erica Chopskie, RN, BS, Allise Taran, MPH, Joseph Bianco, MD, Margaret Evan C. Hadley, MD
Hoberg, CNP, Hillary Henzler Patient Centered Outcomes Research Institute (PCORI), Washington, D.C.
HealthCare Partners, El Segundo, CA Steven B. Clauser, PhD, MPA
Site Principal Investigator: Jeremy Rich, DPM, Fall Care Manger: Vivian Data and Safety Monitoring Board
Chavez, RN, Christine Moore, Janelle Howe, Rosario Garcia, Jocelyn Nunez, A 9-member Data and Safety Monitoring Board, appointed by the National
Samuel Ho, MD, Yan Chen, MD institute on Aging, oversaw study’s progress and safety, and included:
Johns Hopkins Medicine, Baltimore, MD David Buchner, MD, MPH(Chair); Terry Fulmer, PhD, RN, FAAN; Susan
Site Principal Investigator: Albert W.  Wu, MD, MPH, Jeremy D.  Walston, Ellenberg, PhD; Bonita Lynn Beattie, MPT, MHA; Abby C. King, PhD; Cynthia
MD, Fall Care Manager: Tiffany Campbell, BSN, RN, BMTCN, OCN, Patti J. Brown, MD, MSPH; Laurence Rubenstein, MD; Mary Anne Sterling, CEA;
Ephraim, MPH, Yuri Agrawal, MD, Thomas Prohaska, PhD; Laurence Friedman, MD
Mercy Health Network (Des Moines, IA) and University of Iowa (Iowa Funding Support
City, IA) The STRIDE study was funded primarily by the Patient Centered Outcomes
Site Principal Investigator: Robert Wallace, MD, MSc, Co-Site Principal Research Institute (PCORI), with additional support from the National
Investigator: Carri Casteel, PhD, Fall Care Manager: Angela Shanahan, Institute on Aging (NIA) at NIH. Funding is provided and the award man-
RN-BC, BSN, Julie Weldon MSN RN, Anita Leveke, RN, BSN, CEN, Charles aged through a cooperative agreement (5U01AG048270) between the NIA
Keller, MD, Jeffrey Reist PharmD and the Brigham and Women’s Hospital. The project is part of the Partnership
Michigan Medicine, University of Michigan, Ann Arbor, MI for Fall Injuries Prevention between the NIA and PCORI. This research is
Site Principal Investigator: Neil Alexander, MD, Jocelyn Wiggins, BM, BCh, partially supported by the Boston Claude D.  Pepper Older Americans
Fall Care Managers: Karen Burek, RN, MS, ANP-BC and Tina Ledesma, Independence Center at Brigham and Women’s Hospital (P30-AG013679)
RN, BSN, Linda V. Nyquist, PhD, Nancy (Amby) Gallagher, PhD, APRN-BC, and Harvard Catalyst | The Harvard Clinical and Translational Science
Catherine Hanson, BA Center (National Center for Research Resources and the National Center
Mount Sinai Health System, New York, NY for Advancing Translational Sciences, National Institutes of Health Award
Site Principal Investigator: Fred Ko, MD, MS, Albert L.  Siu, MD, MPH, UL1 TR001102) and financial contributions from Harvard University
Rosanne M.  Leipzig, MD, PhD, Christian Espino, BA, Ravishankar and its affiliated academic healthcare centers. Support was also provided
Ramaswamy, MD, MS, Fall Care Managers: Deborah West, RN, BS and by the Claude D.  Pepper Older Americans Independence Centers at UCLA
Deborah Matza, RN, MPH (P30AG028748); Yale (P30AG021342); Mt Sinai (P30AG2874106); UTMB
Partners Healthcare, Boston, MA (P30AG024832), University of Michigan (P30AG024824) and Wake Forest
Site Principal Investigator: Patricia Dykes, RN, PhD, MA, Hilary Stenvig, Kety (P30AG021332). Mt Sinai also received support through a grant from the
Vanda, Alejandra Salazar, PharmD, Laura Frain, MD, Ariela Orkaby, MD, New York Academy of Medicine. Additional support at Yale University was
MPH, Jonathan Bean, MD Fall Care Managers: Yvette Wells, RN and Cathy provided by the NIH/National Center for Advancing Translational Sciences
Foskett, RN Clinical and Translational Science Awards program (UL1TR000142) and an
Reliant Medical Group, Worcester, MA Academic Leadership Award (K07AG043587) to Dr Gill from the National
Site Principal Investigator: Jerry H. Gurwitz, MD, Allison Richards, Lawrence Institute on Aging. Dr. McMahon was supported by grants KL2TR000113
Garber, MD, Fall Care Managers: Peggy Preusse, RN and Anne McDonald, RN and UL1TR000114. The University of Michigan also received support from
University of Pittsburgh Medical Center, Pittsburgh, PA Michigan Medicine, its academic healthcare system. The content of this pub-
Site Principal Investigator: Susan L.  Greenspan, MD, Fall Care Manager: lication is solely the responsibility of the authors and does not necessarily
Mary Anne Ferchak, RN, BS, Madeline Rigatti, Joseph Madia represent the official views of the National Institutes of Health.
University of Texas Medical Branch at Galveston, Galveston, TX
Site Principal Investigator: Elena Volpi, MD, Fall Care Manager: Summer
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